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aren't you being a little conservative with those numbers. isn't Nonillion dollars more realistic?
I guess the moderator must be asleep. You're 30 cents away from knowing exactly how big of an idiot you are
mic drop!
"... DCVAX-L, in combination with other products, may prove to cure many people with a variety of cancers that wouldn't be cured without it." So far DCVAX alone or in combination hasn't cured anything. Even the most charitable reading of the phase iii results only added ~3 months of life expectancy. Which may have had more to do with the type of patients chosen for the trial than DCVAX-L. That's your definition of tremendous success or just your hopes for the stock?
The latter goes away with the introduction of dcvax but the cancer won't
You're making my point. DCvax isn't a silver bullet. It may not even be a rubber bullet.
Biden's cancer moonshot is a ambitious plan to end cancer as we know it. A cure in other words. DCVAX is not a cure. At best it is a treatment that along with SOC. Phase III clinical trial, the median overall survival for newly diagnosed patients receiving DCVax-L was 19.3 months from randomization (22.4 months from surgery), compared to 16.5 months for those receiving standard care alone. Does that sound like a cure to you?
you should define works. dcvax certainly is not a cure as you have often claim
Timothy 6:9-10 is more applicable to you than Matthew 13:44 is to NWBO.
you have no clue concerning the "quality" of the application. you're just trying to pump the stock.
hopefully, you're not the sap in the family tree
I think you made this up. Hard to believe Harvard would post a David vs. Goliath tale where David wins since Harvard Law school cranks out lawyers that are hired by Goliath.
maybe he should sign it Dr. Nemesis18 that should make it look official
Do you really think that Big Pharma is going to let this company rake in the large profits
and I suppose you think the US government has recovered space aliens and are concealing them in area 51 to help Biden win the election
well, it is't going to be available anytime soon (if ever) in the US. NWBO hasn't even submitted to the FDA. You would think, if what you claim is even true, that the insurance company would be working with and helping with NWBO to get approvals. But nothing
first of all, it is not a fact the NWBO will prevail. That's your desperate hope. despite the gratuitous and self serving pumping there are numerous reasons to be pessimistic about NWBO. But you already know that.
this one is right up there with the moon landing hoax open up your history book
talk about being caught up in conspiracy theories! You forgot to include extraterrestrial spacemen working against NWBO because cancer cells are used to fuel their warp drives.
would application acceptance also be considered a material event?
The problem with you time line is it has the wrong starting point. It starts from when the application is accepted not submitted. I haven't seen any PR about that yet
how do you know the application was accepted? I haven't seen any PR other than the Dec 21st submittal
if you really believe that go try and get financing for your new Bentley with that as collateral
i doubt the king and princess would have to wait for approval tell you all you need to know
When I see the PR on MAA approval I'll say great news.
why don't you show where MHRA prohibits it.
This board has been talking about Flaskworks years now.
bet you had to deep into your bag of pejoratives for that one. it's pathetic that when someone expresses a honest contrarian opinion from kool-aid drinkers the knives come out.
Didn't really see anything in the Flaskworks PR that was already know to some degree. The PR probably has more to do about stemming the downward trajectory of the stock price than anything else. Where is the PR about MAA accepting the application? That should have happened by now. Typically, the MHRA allows companies to announce the acceptance of their MAA. So where is it?
How do you know Flaskworks is using an FPGA? It doesn't even make sense. Microcontrollers incorporate security too and cost a fraction of the price. Please provide link to schematic.
it's back in the 50s why not buy another 100K shares.then you can reap the rewards
Even that pace seems optimistic. The application is probably on the very technical side. So, it's more than glancing at 2 or 3 pages a minute all day for 7 years without even a bathroom break. The MAA should be reviewing the application very skeptically. Otherwise it's just a rubber stamp.
Wouldn't it be irresponsible not to review the raw material and just rely on the conclusions?
I agree acceptance of an application will have zero effect on the SP. Rejection might. I read, but do not know for certain, the application is 1.7 million pages. That seems rather large. Hard to imagine how something that big could be processed in the 150 day window. From what I've read 1.7 million pages would indeed be an extremely large number of pages for a typical MAA. In practice, such a massive volume of documentation would likely be considered excessive and far beyond what is customary or necessary for a standard MAA submission.
Most MAAs consist of extensive documentation that includes data from preclinical studies, clinical trials, manufacturing processes, pharmacovigilance, quality control, regulatory documents, and more. However, the number of pages tends to vary widely based on the specific drug, its complexity, and the amount of data generated during the development and testing phases.
Submitting an MAA with 1.7 million pages would be highly unusual and could raise concerns regarding the relevance, completeness, and manageability of the submitted information. Regulatory agencies generally prefer concise, well-organized, and relevant data to facilitate their review processes efficiently.
If such a large number of pages were indeed part of an MAA, it would likely require extensive resources and time for regulatory authorities to review, potentially leading to delays in the evaluation and approval process.
you must not be in good standing with god. i've noticed none of your prayers ever seem to be answered. no news at 3 or 4 or 5 or 6 or...
and your comments are just that your opinion. You can keep praying all you want, but if god was interested in putting his thumb on the scale I would have thought he could have done a better job. A MAA application shouldn't take this long to put together especially since TLD was a couple of years ago and if NWBO was actually interested in getting something submitted. Seems more likely the so call delays are related to not being able to fudge the data to match the con. Something you and NWBO has know for some time.
Yout statement regarding Progression-Free Survival (PFS), Overall Survival (OS), and the evaluation of NWBO's progress contains several misunderstandings that need clarification.
Firstly, it's essential to correct the notion that PFS is a mere "basic statistical guess." Progression-Free Survival is a clinically significant endpoint in oncology trials, providing crucial information about the efficacy of treatments in delaying disease progression. It is not a guess but a scientifically established measure used to assess the impact of therapies on the course of a disease.
The assertion that OS data results hold more weight than PFS in clinical trials is inaccurate. Both PFS and OS are valuable endpoints, each providing unique insights into the effectiveness of treatments. OS measures the overall survival of patients from any cause, while PFS evaluates the duration without disease progression. These metrics offer complementary information, and neither is considered superior to the other; both are vital in evaluating treatment efficacy.
Implying that the FDA solely relies on OS data to determine the progress of a company's treatment is misleading. The FDA evaluates a range of endpoints, including PFS, OS, safety data, and other factors, to comprehensively assess the benefit-risk profile of a treatment. The agency does not base its evaluations solely on one specific endpoint.
Furthermore, while patient testimonies are valuable in understanding the patient experience, they do not constitute scientific evidence in the context of clinical trials. Regulatory bodies such as the FDA prioritize rigorous scientific data obtained from well-designed clinical trials rather than anecdotal evidence when evaluating the efficacy and safety of treatments. Clearly, NMBO's clinical trials were anything but well-designed.
In conclusion, it is crucial to accurately represent the significance of PFS and OS as distinct but equally important endpoints in clinical trials. Additionally, it's important to emphasize that the FDA's evaluation process considers multiple factors beyond OS and does not rely on patient testimonials as primary evidence. Precision, clarity, and adherence to scientifically validated data are essential in discussions about treatment efficacy and regulatory assessments.
your problem is counting your chickens before they hatch. you must be scratching your wattles wondering why the stock isn't at $100/share.
Several issues with your analysis (as usual). In this case, the Success-Run Theorem predicts sample size needed to achieve a desired confidence level based on a large number of production units. When you have a small number of units, it may not be a sufficient representation of the underlying probability distribution. In such cases, the observed outcomes can be heavily influenced by randomness, and the results may not align well with the theoretical predictions of the theorem. With a small sample size, you might observe outcomes that are far from the expected average. For example, you could achieve the desired pattern of consecutive successes in very few trials due to luck, or it might take many more trials than expected due to the inherent variability in a small sample. Of course, the success-run theorem doesn't provide any clue into the reliability of the units just that a functional test passed. If you really were involved in 100s of products over 40 years, you would know that functional tests especially early on in production may not be that reliable. Assuming your definition of 100s is 100 then that is 2.5 products a year. None of those products could be very complicated. Maybe you were in the toy wooden blocks business.
It's a case against MAA or FDA approval.
here's one for you.
https://www.nature.com/articles/s41416-023-02194-1